Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension

NCT ID: NCT01198249

Last Updated: 2011-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-03-31

Brief Summary

This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

amlodipine monotherapy

Group Type: EXPERIMENTAL

multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide

Intervention Type: DRUG

amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study

losartan monotherapy

Group Type: EXPERIMENTAL

multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide

Intervention Type: DRUG

amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study

HCTZ

Group Type: EXPERIMENTAL

multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide

Intervention Type: DRUG

amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study

mlodipine and Losartan and HCTZ

Group Type: EXPERIMENTAL

multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide

Intervention Type: DRUG

amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study

Interventions

multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide

amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult subjects 20-50 years of age
• Above 55Kg and within ±20% ideal body weight
• Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) < 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) < 100mmHg
• Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
• Subjects who wrote informed consent

Exclusion Criteria

• Subjects who are suspected to have acute disease
• Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
• Subjects who have gastrointestinal history
• Subjects whose heartrate is less than 60
• Subject who suspected to orthostatic hypotension
• Subjects who have clinically significant allergy disease
• Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
• Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
• Subjects who have past history of drug abuse and positive in drug screening test
• Subjects who donate whole blood within 60 days and platelet within 30days.
• Subjects taking St John's wort or CYP inhibitor and inducer

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Hanmi Pharmaceutial Co., Ltd.

Principal Investigators

Jae-Yong Chung, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2010-0295

Identifier Type: -

Identifier Source: org_study_id